Effect of Xolair on Airway Hyperresponsiveness - Full Text View

Sponsors and Collaborators:	Creighton University Genentech
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00208234

Purpose

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Condition	Intervention	Phase
Allergic Asthma	Drug: Omalizumab Drug: Placebo for Omalizumab Drug: omalizumab	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness

Further study details as provided by Creighton University:

Primary Outcome Measures:

To determine if treatment with omalizumab induces changes in PC20 values to methacholine bronchoprovocation challenges and/or PC15 values to hypertonic saline-induced bronchoprovocation challenges in a time-dependent manner in steroid naive subjects [ Time Frame: post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine in steroid naive allergic asthma subjects whether omalizumab decreases exhaled NO and sputum eosinophilia, markers of airway inflammation, in time-dependent fashion and to correlate these effects with those measured for airway responsiveness [ Time Frame: post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	January 2004
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: Placebo Comparator Placebo	Drug: Placebo for Omalizumab Placebo
2: Experimental Omalizumab	Drug: Omalizumab 0.016 mg/kg IgE Drug: omalizumab Monoclonal antibody against IgE. 0.016 mg/kg IgE

Detailed Description:

Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergic asthmatic patients, Xolair reduced asthma exacerbations and improved symptoms. However, there is limited data on the effects of Xolair on airway hyperreactivity, an important component of asthma.

Eligibility

Ages Eligible for Study:	19 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.
History of mild to moderate asthma
A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagiodes farinae, or dermatophagoides pteronyssinus)
A PC20 value for methacholine < 5 mg/mL
A PC15 value for hypertonic saline at < 4 minutes
Capable of faithfully attending regularly scheduled study visits
Willing to avoid prohibited medications for the periods indicated in the protocol
A baseline serum IgE level of > 30 IU/mL and < 700 IU/mL

Exclusion Criteria:

Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding
Known sensitivity to study drug or class of study drug
Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit
Patients with a history of severe anaphylactoid or anaphylactic reactions
Patients taking beta-adrenergic antagonists in any form
Patients previously exposed to Xolair
Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs
Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations
Use of immunosuppressive medications
History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208234

Contacts

Contact: Jean Kessler, RN, CCRC

402-280-5965

Locations

United States, Nebraska
Creighton University Division of Allergy & Immunology	Recruiting
Omaha, Nebraska, United States, 68131
Contact: Jean Kessler, RN, CCRC 402-280-5965
Principal Investigator: Thomas Casale, MD

Sponsors and Collaborators

Creighton University

Genentech

Investigators

Principal Investigator:

Thomas B Casale, MD

Creighton University School of Medicine

More Information

No publications provided

Responsible Party:	Creighton University ( Robert G. Townley, MD )
Study ID Numbers:	Xolair Asthma
Study First Received:	September 14, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00208234 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

asthma

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Anti-Asthmatic Agents
Asthma

Anti-Allergic Agents
Immunoglobulins
Omalizumab

Additional relevant MeSH terms:

Respiratory System Agents
Therapeutic Uses
Anti-Asthmatic Agents

Anti-Allergic Agents
Pharmacologic Actions
Omalizumab

ClinicalTrials.gov processed this record on May 07, 2009